By Kim Coghill
Biopure Corp.'s stock jumped 27 percent Tuesday after the company said South Africa's Medicines Control Council (MCC) approved Hemopure, an oxygen therapeutic, for human use in the treatment of acute anemia and avoidance of red blood cells in adult surgery patients.
The marketing application in South Africa included data from 20 human clinical trials conducted during the past nine years in the U.S., Europe, South Africa and Canada. The data included three completed, advanced trials comparing Hemopure to red blood cell transfusion in cardiac, vascular and general surgeries and additional supportive data.
Biopure's stock (NASDAQ:BPUR) closed Tuesday at $19.77, up $4.18.
Sam Chang, an associate analyst with Salomon Smith Barney Inc. in San Francisco, said the South African market is rather small, but 2002 sales are expected to reach between $3 million to $5 million. By 2003, worldwide sales should be $77 million, he said.
Carl Rausch, CEO and co-founder of Cambridge, Mass.-based Biopure, said he expects to file a new drug application with the FDA in August or September, and anticipates approval in the U.S. a year later.
The company sought approval in South Africa first because "it was a natural outgrowth of our trial plan and also our plan for approval," said Edward Jacobs, Biopure's senior vice president of medical affairs. "The product has been in human trials for nine years, six of which were conducted solely in the U.S., and after we had established a good safety profile, we expanded our clinical trials to Europe and South Africa and eventually Canada."
While conducting the trials in South Africa, Jacobs said those in the medical community there expressed a great interest in Hemopure "and were extremely keen for something new that would work, and they made a great contribution to our clinical trials."
It was based on the interest in South Africa that Biopure stepped up efforts to begin working with the MCC for evaluation and eventual approval.
"It is very gratifying [to receive approval] and I think it reflects 17 years of development work by a very dedicated team of professionals who have come together to work very hard and do something that has been very difficult to do," Jacobs said. "We hope there are further successes in this area because the body's need for oxygen is continuous and instantaneous and, up until now, only red blood cells could supply that transport function."
The advent of therapeutics, molecules or drugs that can carry oxygen in the bloodstream will take medicine to new heights, Jacobs said. "We believe this will open up new therapeutic areas because these products have different characteristics and are actually able to oxygenate tissues - sometimes even better than blood."
Each unit of Hemopure consists of 30 grams of hemoglobin that has been extracted from bovine red blood cells, ultra-purified, chemically cross-linked and formulated in 250 millimeters of balanced salt solution. These stabilized, noncellular hemoglobin molecules circulate in plasma when infused and are much smaller, have lower viscosity and more readily release oxygen to tissues than red blood cells. Consequently, they can carry oxygen at low pressure through constricted or partially blocked blood vessels to areas of the body that red blood cells cannot reach.
Biopure's patented 22-step pharmaceutical manufacturing process for Hemopure incorporates raw material controls to prevent the introduction of pathogens and employs purification techniques that have been validated to remove or inactivate potential infectious agents, including bacteria, viruses such as HIV and hepatitis C, and transmissible spongiform encephalopathy agents.
Biopure has contracted South Africa-based health care provider Network Healthcare Holdings Ltd., or "Netcare," and Community Healthcare Holdings Ltd. to exclusively market and distribute the product in sub-Saharan Africa.
Rausch said Biopure owns Hemopure in the rest of the world, including the U.S., but is exploring a partnership in Europe.
And while Hemopure has been approved for all surgeries in South Africa, Jacobs said the company hasn't decided which indications it will request approval for in the U.S.
Rausch added, "This certainly is a momentous time in the nature of dealing with a new paradigm for patient management. It is truly a very rewarding time to be able to bring such a health care change to the marketplace."
He said in the coming months, as the product is used in South Africa, "I think we will see some very significant clinical use of the product, which is outside the construct of very rigid clinical trials. That doesn't mean there will be off-label use. It means you will get a true read on the use of the product because the clinical trials are meant to do one thing: You are trying to show an approval pathway for the product."
Biopure also owns a similar product, Oxyglobin, which is commercially available in the U.S. for the treatment of anemia in dogs.